Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-02-19 @ 9:54 AM
Study NCT ID:
NCT03909451
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2019-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Determine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Orally Administered Sotagliflozin in Healthy Chinese Subjects
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective:
To assess the safety and tolerability of sotagliflozin after a multiple oral dose administration in Chinese healthy subjects.
Secondary Objectives:
* To assess the pharmacokinetic (PK) parameters of sotagliflozin after a multiple oral dose administration in Chinese healthy subjects.
* To assess the pharmacodynamics (PD) parameters of absolute urinary glucose excretion after a multiple oral dose administration in Chinese healthy subjects.
To assess the safety and tolerability of sotagliflozin after a multiple oral dose administration in Chinese healthy subjects.
Secondary Objectives:
* To assess the pharmacokinetic (PK) parameters of sotagliflozin after a multiple oral dose administration in Chinese healthy subjects.
* To assess the pharmacodynamics (PD) parameters of absolute urinary glucose excretion after a multiple oral dose administration in Chinese healthy subjects.
Detailed Description:
The study duration per subject will be up to 41 days and will consist of a screening period of up to 28 days, a dosing period of 8 days, and a follow up visit 5 days after last dosing.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1199-6171 | OTHER | UTN | View |